Consideration of Biological Sex in Translating Regenerative Stem Cell Therapies

Regenerative cell therapies are emerging as the next major development in medicine. Stem cell therapies are defined as any treatment based on viable human stem cells including adult stem cells, embryonic stem cells, and induced pluripotent stem cells. Their ability to self-renew and potential to differentiate into multiple cell types has led to many clinical trials for tissue regeneration, immune modulation, and cancer therapy among other indications. The challenges surrounding commercial viability and clinical uptake of novel therapies are related to difficulties in establishing clinical utility and cost-effectiveness. Only recently has gender bias come to light as a potentially critical pitfall in translational research. Future stem cell strategies should be based on research that has considered sex as a biological variable throughout the biomedical development spectrum to maximize positive outcomes and avoid gender bias. In this review, we focus on the implications of biological sex on translational regenerative stem cell therapies, and consider the limitations of the present body of knowledge.